Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes, Diabetes Mellitus, Type 2, Cholesterolemia
In brief
12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C
Key facts
- Study ID
- NCT03531905
- Run by
- Esperion Therapeutics, Inc.
- People needed
- 242
- Starts
- 2018-05-09
- Expected to finish
- 2019-06-18
- Last updated by the study team
- 2020-04-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 2 diabetes for 6 months or greater
- Currently taking stable diabetes medication for 3 months or greater
- HbA1c between 7-10%
- LDL-cholesterol greater than 70 mg/dL
- Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of study medication; and must be postmenopausal, surgically sterile, or willing to use 1 acceptable form of birth control during the study through 30 days after the last dose of study medication
You may not qualify if…
- Body mass index > 40 kg/m2
- History of documented clinically significant cardiovascular disease
- Fasting triglycerides > 400 mg/dL
- History of Type 1 diabetes
- Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal condition that may affect drug absorption, hematologic or coagulation disorder or active malignancy
- History of drug or alcohol abuse within 2 years
Where it is running
- Clinical Trials Research — Lincoln, California, United States
- FInlay Medical Research — Miami, Florida, United States
- L-MARC Research Center — Louisville, Kentucky, United States
- Hampton Roads Center for Clinical Research — Suffolk, Virginia, United States
Full record on ClinicalTrials.gov
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